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Melatonin and fibromyalgia: an active-comparator pilot

The trial compared melatonin, amitriptyline and their combination, rather than an untreated placebo group.

Read the evidence ↓

Supplement Science Insights Editorial Team

Published September 23, 2026

The study and its comparison

Sixty-three women with fibromyalgia were randomized to three blinded treatment groups for six weeks: amitriptyline, melatonin, or both. Investigators measured pain, function and experimental pain modulation. [1]

Melatonin-containing groups had greater pain-score reductions than amitriptyline alone. The combination showed additional changes in selected functional and pain-threshold measures, which the authors described as only marginal added clinical effects. [1]

What the finding establishes

The small groups and short follow-up limit certainty. Without an inert-placebo-only arm, the comparison does not estimate each treatment’s full effect against no active medication. Funding and conflicts were not established from the abstract. The trial does not justify independently combining medicines or generalizing to every chronic-pain condition. [1]

A hypothetical distinction

Imagine all study groups receive an active treatment. Their differences answer a comparative question, not the same question as treatment versus placebo.

Interpretation checklist — Melatonin and fibromyalgia
DetailInterpretation
Measured outcomeKeep the endpoint specific
Study preparationNot every retail product
Remaining uncertaintyNot resolved by a mechanism
Melatonin and fibromyalgia: an active-comparator pilot — original article outline diagram
Original editorial diagram of this article’s sections; no product photograph or clinical finding is depicted.

Sources for this article

  1. Melatonin analgesia is associated with improvement of the descending endogenous pain-modulating system in fibromyalgia: a phase II, randomized, double-dummy, controlled trial.
    Source consulted: 2026-09-19. This is a reference resource, not a claim that we conducted the studies or tested a product.